A trial of Itraconazole or Amphotericin B HIV-associated talaromycosis
| Autor: | Jeremy N. Day, Ngo Thi Kim Cuc, Do Duy Cuong, Nguyen Tien Lam, Nguyen Van Kinh, Nguyen Van Vinh Chau, Vu Hai Vinh, Nguyen T. Hang, Marcel Wolbers, Laura Merson, Pham T.H. Phuc, Heiman F. L. Wertheim, Ho T. Nhan, Pham Thi Thu Thuy, Nguyen Le Nhu Tung, Vu Van Tam, Nguyen Thi My Thanh, Guy E. Thwaites, Cecilia M. Shikuma, Jeremy Farrar, Hoang B. Long, Doan T.H. Hanh, Tran Phuong Thuy, Thuy Le |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Drug medicine.medical_specialty business.industry Itraconazole media_common.quotation_subject 030106 microbiology Induction chemotherapy General Medicine Gastroenterology Surgery law.invention Clinical trial 03 medical and health sciences lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] Maintenance therapy Randomized controlled trial law Internal medicine Amphotericin B deoxycholate Amphotericin B Medicine business medicine.drug media_common |
| Zdroj: | The New England Journal of Medicine, 376, 2329-2340 The New England Journal of Medicine, 376, 24, pp. 2329-2340 |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | Item does not contain fulltext BACKGROUND: Talaromyces marneffei infection is a major cause of human immunodeficiency virus (HIV)-related death in South and Southeast Asia. Guidelines recommend initial treatment with amphotericin B deoxycholate, but this drug has substantial side effects, a high cost, and limited availability. Itraconazole is available in oral form, is associated with fewer unacceptable side effects than amphotericin, and is widely used in place of amphotericin; however, clinical trials comparing these two treatments are lacking. METHODS: In this open-label, noninferiority trial, we randomly assigned 440 HIV-infected adults who had talaromycosis, confirmed by either microscopy or culture, to receive either intravenous amphotericin B deoxycholate (amphotericin) (219 patients), at a dose of 0.7 to 1.0 mg per kilogram of body weight per day, or itraconazole capsules (221 patients), at a dose of 600 mg per day for 3 days, followed by 400 mg per day, for 11 days; thereafter, all the patients received maintenance therapy with itraconazole. The primary outcome was all-cause mortality at week 2. Secondary outcomes included all-cause mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, development of the immune reconstitution inflammatory syndrome (IRIS), and the side-effect profile. RESULTS: The risk of death at week 2 was 6.5% in the amphotericin group and 7.4% in the itraconazole group (absolute risk difference, 0.9 percentage points; 95% confidence interval [CI], -3.9 to 5.6; P |
| Databáze: | OpenAIRE |
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